Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant
2 other identifiers
interventional
79
3 countries
15
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2016
Shorter than P25 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2016
CompletedFirst Posted
Study publicly available on registry
May 24, 2016
CompletedStudy Start
First participant enrolled
July 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2017
CompletedResults Posted
Study results publicly available
August 21, 2018
CompletedNovember 14, 2018
July 1, 2018
1 year
May 20, 2016
July 25, 2018
October 19, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
Up to 12 weeks
Secondary Outcomes (14)
Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
Posttreatment Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 2
Week 2
Percentage of Participants With HCV RNA < LLOQ at Week 4
Week 4
Percentage of Participants With HCV RNA < LLOQ at Week 8
Week 8
Percentage of Participants With HCV RNA < LLOQ at Week 12
Week 12
- +9 more secondary outcomes
Study Arms (1)
SOF/VEL
EXPERIMENTALSOF/VEL FDC for 12 weeks
Interventions
400/100 mg tablet administered orally once daily
Eligibility Criteria
You may qualify if:
- History of chronic HCV infection (≥ 6 months)
- HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
- Liver transplant ≥ 3 months prior to screening
- Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis
You may not qualify if:
- History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
- Co-infection with HIV or hepatitis B virus
- Known hypersensitivity to study medication,
- Use of any prohibited concomitant medications as within with window before the Day 1 visit.
- De novo or recurrent hepatocellular carcinoma posttransplant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (15)
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Reina Sofía University Hospital
Córdoba, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Ramón Y Cajal
Madrid, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
La Fe Hospital
Valencia, Spain
Hospital Clinico Zaragoza
Zaragoza, Spain
Universität Bern
Bern, Switzerland
University Hospital Zurich
Zurich, Switzerland
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, United Kingdom
St James University Hospital
Leeds, United Kingdom
Kings College Hospital
London, United Kingdom
Royal Free Hampstead NHS Trust
London, United Kingdom
Related Publications (1)
Agarwal K, Castells L, Mullhaupt B, Rosenberg WMC, McNabb B, Arterburn S, Camus G, McNally J, Stamm LM, Brainard DM, Mani Subramanian G, Marino Z, Dufour JF, Forns X. Sofosbuvir/velpatasvir for 12 weeks in genotype 1-4 HCV-infected liver transplant recipients. J Hepatol. 2018 Sep;69(3):603-607. doi: 10.1016/j.jhep.2018.05.039. Epub 2018 Jun 8.
PMID: 29886154BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
May 24, 2016
Study Start
July 27, 2016
Primary Completion
July 28, 2017
Study Completion
July 28, 2017
Last Updated
November 14, 2018
Results First Posted
August 21, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.